Gur­net Point-backed Au­re­gen taps Am­gen vet to lead; Ex-Roche RNA chief takes CEO post at Genevant

Gur­net Point Cap­i­tal-backed Au­re­gen Bio­Ther­a­peu­tics has tapped Am­gen vet Richard Davies to lead its rare dis­ease cell ther­a­py’s en­try in­to the clin­ic as CEO. Davies, a for­mer Hos­pi­ra chief com­mer­cial of­fi­cer who had his first chief ex­ec­u­tive ex­pe­ri­ence re­cent­ly at Bone­sup­port, will lead the dri­ve in trans­lat­ing the Gene­va-based biotech’s 3D bio­fab­ri­ca­tion tech­nolo­gies to new ther­a­peu­tics, start­ing from a pro­gram in rare con­gen­i­tal cran­io­fa­cial dis­or­ders.

→ Brick­ell Biotech has hired in­dus­try vet­er­an and Lil­ly $LLY Chief Mar­ket­ing Of­fi­cer Robert Brown to take the reins at the der­ma­tol­ogy com­pa­ny as it preps a late-stage tri­al eval­u­at­ing its drug, sof­piro­ni­um bro­mide, in pa­tients with ex­ces­sive un­der­arm sweat­ing in the first half of 2019. Brown, who has spent over three decades at Lil­ly, is set to re­place Brick­ell’s cur­rent CEO and co-founder Regi­nald Hardy on Jan­u­ary 1.

Bo Rode Hansen is step­ping up from a CSO po­si­tion to take the top job at Genevant. Un­like the rest of Vivek Ra­maswamy’s biotech fam­i­ly, the com­pa­ny is not in-li­cens­ing late-stage pro­grams, but build­ing a pipeline from scratch us­ing Ar­bu­tus’ RNA tech, with the aim of de­liv­er­ing more than five in-house and part­nered can­di­dates for clin­i­cal de­vel­op­ment by 2020. Hansen, the for­mer glob­al head of RNA at Roche with 50 dis­cov­ery pro­grams un­der his belt, will play a lead­ing role along­side a sea­soned ex­ec team.

→ A year af­ter Mary Szela left the helm of Nov­e­l­ion Ther­a­peu­tics $NVLN, the rare dis­ease biotech is shak­ing up its CEO of­fice again. Jef­frey Hack­man, the for­mer COO who’s been fill­ing in, has re­signed as in­ter­im CEO, pass­ing the re­spon­si­bil­i­ties to gen­er­al coun­sel Ben­jamin Harsh­barg­er. Hav­ing helped se­cure a re­cent loan fa­cil­i­ty, Harsh­barg­er is charged with the grand turn­around mis­sion by first fix­ing the cap­i­tal struc­ture.

→ Al­most a year af­ter step­ping down from Syn­er­gy Phar­ma­ceu­ti­cals — a com­pa­ny he found­ed and co-in­vent­ed the lead drug for — Gary Ja­cob has land­ed at a mi­cro­bio­me biotech in Aus­tralia. As CEO, Ja­cob is ex­pect­ed to chan­nel both his de­vel­op­ment, fi­nan­cial and com­mer­cial ex­per­tise in steer­ing Im­muron’s $IM­RN pipeline of oral­ly de­liv­ered poly­clon­al an­ti­bod­ies, which is led by a pro­gram for liv­er dis­eases.

→ Fol­low­ing a wide-rang­ing ca­reer fea­tur­ing stints at No­var­tis, L’Ore­al and SBM Man­age­ment Ser­vices, Stephan Jack­man has been ap­point­ed CEO of Alza­mend Neu­ro, a biotech de­vel­op­ing a cou­ple of Alzheimer’s drug can­di­dates out of the Uni­ver­si­ty of South Flori­da. Pri­or to the new role, Jack­man was fo­cused on ad­vanc­ing cures for mos­qui­to borne in­fec­tious dis­eases as COO of En­naid Ther­a­peu­tics.

→ New­ly pub­lic Ma­gen­ta Ther­a­peu­tics $MG­TA has scooped Ja­son Ryan from Foun­da­tion Med­i­cine to be its chief op­er­at­ing and fi­nan­cial of­fi­cer. The high fly­ing Cam­bridge start­up, which has a port­fo­lio fo­cused on bone mar­row trans­plant, can ben­e­fit from Ryan’s ex­pe­ri­ence in cap­i­tal cre­ation and al­lo­ca­tion as well as com­mer­cial plan­ning, says CEO Ja­son Gard­ner, as demon­strat­ed in his ef­forts with Foun­da­tion’s re­cent sale to Roche.  

→ Gothen­burg, Swe­den-based Iso­fol has hired Roger Tell — a bio­phar­ma vet who’s al­so run mul­ti­ple tri­als as a prin­ci­pal in­ves­ti­ga­tor — to run its clin­i­cal pro­gram as it ad­vances its lead prod­uct can­di­date in­to Phase III. Ar­foli­tixorin, de­vel­oped through a part­ner­ship with Mer­ck KGaA, is de­signed to boost the ef­fects of chemother­a­py main­ly in col­orec­tal can­cer. As CSO and SVP of clin­i­cal de­vel­op­ment, Tell will al­so over­see  sci­en­tif­ic re­search and tech­ni­cal op­er­a­tions.

→ With its Phase III pro­grams well un­der­way, Apel­lis Phar­ma­ceu­ti­cals $APLS has tapped Adam Townsend to plot a mar­ket­ing plan for APL-2 — its com­ple­ment C3 in­hibitor look­ing to ri­val Soliris in parox­ys­mal noc­tur­nal he­mo­glo­bin­uria — and al­so build a fran­chise in ge­o­graph­ic at­ro­phy, an ad­vanced form of age-re­lat­ed mac­u­lar de­gen­er­a­tion. The new chief com­mer­cial joins from Bio­gen, where he helped lead the launch­es of Tec­fidera and Spin­raza.

→ Fol­low­ing an 11-year ca­reer run­ning clin­i­cal op­er­a­tions for mul­ti­ple units — in­clud­ing the oph­thalmic fran­chise — at No­var­tis, Fabio Baschiera is jump­ing to an oph­thal­mol­o­gy start­up backed by the phar­ma gi­ant. His new ti­tle at Oculis will be VP of clin­i­cal de­vel­op­ment. Al­so join­ing the Swiss biotech: Louie-Anne Gau­thi­er, who will now scout deals for Oculis’ eye drop al­ter­na­tives for in­jectable drugs as its VP of strate­gic mar­ket­ing, busi­ness de­vel­op­ment and li­cens­ing.

Ven­ture Cap­i­tal as a Strate­gic Part­ner: Fu­el­ing In­no­va­tion be­yond Fi­nance

The average level of investment required for a biotech start-up to succeed is increasing every year, elevating the pressure even further on venture capital to make smart financial investments. Financial investment alone, however, does not always guarantee that exciting innovations can be transformed into real businesses that make a meaningful difference to patients.

Beyond just capital

At Astellas Venture Management (AVM) – a wholly-owned venture capital organization within Astellas, headquartered in the San Francisco Bay Area – capital is just one of the ingredients we offer to add value to our biotechnology investments and partnerships. We generally take a strategic investor approach for companies in our invested portfolio, providing access to expertise, technology and/or resources in addition to the injection of finance. An equity investment from AVM can include access to Astellas’ research and development (R&D) capabilities and expertise, and a global network of partner academic institutions and biotechnology companies, to help advance and accelerate the start-up’s innovation.

UP­DAT­ED: Ver­tex joins Mer­ck, Pfiz­er — re­vamp­ing multi­bil­lion-dol­lar tri­al strat­e­gy as biotech R&D crum­bles

You can add Pfizer, Merck and — as we found out Friday morning — Vertex to the growing list of pharma giants hitting the pause button on a range of clinical trials. But not everyone in R&D is getting a red light.

Vertex says that it’s doing its best to keep working its pipeline strategy, coming up with a plan “to enable virtual clinic visits and home delivery of study drug to ensure study continuity and medical monitoring, and to facilitate study procedures.”

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Covid-19 roundup: In­ter­cept, blue­bird and a grow­ing list of biotechs feel the pain as pan­dem­ic man­gles FDA, R&D sched­ules

Around 100 staffers at Boston area hospitals have now tested positive for Covid-19, spotlighting the growing risk that the pandemic will sideline many of the most essential workers in healthcare as caseloads peak in the US and around the globe. With more than 3,400 deaths, Spain has become the latest country to surpass the official death count attributed to the new coronavirus in China, where the outbreak originated. As of Thursday morning, confirmed global cases had crossed 470,000 and the death count eclipsed 21,000.

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Af­ter crit­ics lam­bast­ed Gilead for grab­bing the FDA's spe­cial rare drug sta­tus on remde­sivir, they're giv­ing it back

Two days after Gilead won orphan drug status for remdesivir as a potential treatment for Covid-19, they’re handing it back.

The company was slammed from several sides after Gilead reported that the FDA had come through with the special status, which comes with 7 years of market exclusivity, the waiver of FDA fees and some tax credits as well. Typically, everyone who can get orphan status lands it without much of a fuss, but Democratic presidential candidate Bernie Sanders, Public Citizen and other consumer groups were outraged.

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Mod­er­na CEO Stéphane Ban­cel out­lines a short path for emer­gency use of a coro­n­avirus vac­cine

NIAID director Anthony Fauci has left no doubts that it takes 12 to 18 months to get a new vaccine tested and in commercial use, in the best of circumstances. But in times of a global emergency — like these — maybe there’s another, faster route to follow.

In an SEC filing on Tuesday, Moderna $MRNA staked out a record-setting pathway to getting their mRNA vaccine into the frontline of the healthcare response as early as this fall. The SEC filing notes that CEO Stéphane Bancel told Goldman Sachs that an emergency use approval could allow the vaccine to go to healthcare workers and certain individuals in a matter of months — presumably provided the NIH sees the safety and efficacy data they would need from the Phase I.

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Caught in a Covid-19 mael­strom, Eli Lil­ly locks down clin­i­cal tri­als as multi­bil­lion-dol­lar R&D ops de­rail

The Covid-19 pandemic has derailed Eli Lilly’s $6 billion R&D operations.

The pharma giant reported Monday morning that it has decided to hit the brakes on most new study starts and pause enrollment for most ongoing studies. Lilly adds that it is continuing dosing for ongoing studies, “but with study-by-study consideration.”

The pandemic has severely disrupted healthcare systems around the globe, says Lilly, making it difficult or impossible to conduct studies at many research sites. And there’s no timeline for when it expects to get back on track.

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As share buy­backs come un­der scruti­ny, what's in store for the bio­phar­ma in­dus­try?

Stock buybacks are not to be permitted for companies that will be bailed out in the coronavirus stimulus package, Congressional leaders have signaled. To what degree the biopharma industry has relied on buybacks for earnings growth in recent years, and if the trend continues, are the big questions as scrutiny into the practice heightens and balance sheets weaken with the coronavirus pandemic wreaking havoc on global economies.

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A Sin­ga­pore VC rais­es $200M for a new round, but will Covid-19 pre­vent it from rais­ing the rest?

A top Singaporean biotech venture fund is nearly halfway toward its largest ever fund, but in a sign of what could be in store for VCs amid a global economic freeze, said they could face headwinds raising the other half.

Vickers Venture Partners has secured $200 million out of a targeted $500 million for its 6th fund, first announced in early 2018. They’ve given themselves 13 months to complete the financing, Vickers founder Finian Tan told Deal Street Asia, but the financial frost settling amid the Covid-19 pandemic could slow efforts.

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Strug­gling Unum ex­ecs are ready to con­sid­er a sale, merg­er or any deal that comes its way

Unum $UMRX is working its way through a survival plan of sorts.

After getting hit with a trio of FDA holds in its brief public history and triggering its second pivot to a new lead drug program while laying off 60% of the staff, the troubled penny stock biotech Unum Therapeutics has hatched new plans to secure financial backing while lining up a go-forward strategy for the company.

First, Lincoln Park Capital Fund has agreed to buy up to $25 million of the long-suffering stock, as Unum directs. And the executive team — led by CEO Chuck Wilson — has put everything on the table for consideration: a sale, acquisition, merger, licensing deal, you name it. The ACTR707 program, meanwhile, is being formally wrapped up — their second failed lead program.